Earn Your ISO 13485:2016 Certification
If you work in the startup MedTech industry, you know one of the hardest obstacles to overcome is making sure your medical device is compliant with the rigorous standards set by different organizations. This includes the ISO 13485:2016 standard, which specifies the appropriate quality management system requirements needed for medical devices.
By having your device and QMS certified, you can confidently demonstrate your medical product meets the rigorous requirements for safety and performance for consumers, suppliers, and more.
To learn more about how Cannon Quality Group can help your organization prepare for its ISO 13485:2016 certification, reach out to us today.
What is the ISO 13485 Standard?
ISO 13485 is an internationally recognized standard for assessing a medical device’s quality management system. It’s been adopted from the ISO 9001 QMS standard series and is the world’s most popular standard that has been modified to specifically encompass medical devices.
By being ISO compliant, your medical product satisfies requirements that are upheld throughout the industry, which can offer several benefits, including:
- Increased market access – By earning the ISO 13485 QMS certification, you can instill confidence in business partners, potential investors, and foreign markets.
- A focus on safety and performance – This is the most widely respected standard for quality management systems, meaning a compliant medical device abides by safe design, production, and installation procedures and records. Risk analysis continues to be a key aspect of the standard throughout the product lifecycle.
- Additional insights on how to improve processes – When your quality management system is graded against the top standard in the industry, you’ll be able to identify areas for improvement and ways to increase efficiency.
*It’s important to note if your medical device has been certified to ISO 13485:2003, you are required to transition to the updated 2016 versions by March of 2019.*
To ensure your device remains compliant, contact Cannon Quality Group today, or continue reading about our services below.
Our ISO 13485 Training & Preparation Services
Whether you are new to the standard or need to transition from the previous standards established in 2003 or 2012, Cannon Quality Group is available to help your organization prepare for their medical device QMS certification.
We provide gap assessments and audits to help ensure your medical devices’ quality systems are ISO 13485 compliant. We do this by assessing several factors of your current quality systems, including:
- Document control
- Management responsibility
- Resource management
- Design control
- Risk management
- Production control
- Complaint handling processes
- And more
To learn more about our ISO 13485:2016 preparation and assessment services, contact us online today.
CE Mark Certification for Medical Devices
ISO 13485 also acts as the QMS standard accepted under European regulations for earning the CE mark on medical devices. CE marking represents the manufacturer’s claim that their product is compliant with the appropriate European Medical Device Directives. It is legally required for medical products to be sold in the European Union.
If your medical device is expanding into the European markets and you need the CE mark, you need to start with transitioning or becoming ISO 13485 certified.
Choose Cannon Quality Group for ISO 13485 Assessments & Audits
It’s never been easier to prepare your medical device for ISO 13485 certification. Cannon Quality Group offers years of experience in the medical device industry, qualified auditors, and the flexibility to have your product ready for any deadline.
In addition to assessments and audits for various organizations, Cannon Quality Group also offers the Founders Club program. Membership provides MedTech entrepreneurs with access to a fully equipped medical device QMS testing facility. Our shared space facility offers a Class 7 Controlled Environment Room and other amenities.
To learn more about our Founders Club and how you can become a member, contact Cannon Quality Group online today.